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Last Updated: June 16, 2024

~ Buy the BREZTRI AEROSPHERE (budesonide; formoterol fumarate; glycopyrrolate) Drug Profile, 2024 PDF Report in the Report Store ~

BREZTRI AEROSPHERE Drug Patent Profile


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When do Breztri Aerosphere patents expire, and what generic alternatives are available?

Breztri Aerosphere is a drug marketed by Astrazeneca Ab and is included in one NDA. There are nine patents protecting this drug.

This drug has two hundred and six patent family members in thirty-four countries.

The generic ingredient in BREZTRI AEROSPHERE is budesonide; formoterol fumarate; glycopyrrolate. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the budesonide; formoterol fumarate; glycopyrrolate profile page.

DrugPatentWatch® Generic Entry Outlook for Breztri Aerosphere

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 28, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for BREZTRI AEROSPHERE
Drug patent expirations by year for BREZTRI AEROSPHERE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BREZTRI AEROSPHERE
Generic Entry Date for BREZTRI AEROSPHERE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
AEROSOL, METERED;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for BREZTRI AEROSPHERE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Jianxing HeN/A

See all BREZTRI AEROSPHERE clinical trials

US Patents and Regulatory Information for BREZTRI AEROSPHERE

BREZTRI AEROSPHERE is protected by nine US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BREZTRI AEROSPHERE is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BREZTRI AEROSPHERE

Compositions for pulmonary delivery of long-acting muscarinic antagonists or long-acting B2 adrenergic receptor agonists and associated methods and systems
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Drug delivery systems and related methods
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions, methods and systems for respiratory delivery of two or more active agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Compositions, methods and propellant-based systems for respiratory delivery of glycopyrrolate and one or more active agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Compositions for pulmonary delivery of long-acting .beta..sub.2 adrenergic receptor agonists and associated methods and systems
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Compositions, methods and systems for respiratory delivery of two or more active agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Compositions, methods and systems for respiratory delivery of two or more active agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Compositions for pulmonary delivery of long-acting muscarinic antagonists and associated methods and systems
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122-001 Jul 23, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122-001 Jul 23, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122-001 Jul 23, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122-001 Jul 23, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for BREZTRI AEROSPHERE

When does loss-of-exclusivity occur for BREZTRI AEROSPHERE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 6621
Estimated Expiration: ⤷  Sign Up

Patent: 6806
Estimated Expiration: ⤷  Sign Up

Patent: 6807
Estimated Expiration: ⤷  Sign Up

Patent: 1758
Estimated Expiration: ⤷  Sign Up

Patent: 2477
Estimated Expiration: ⤷  Sign Up

Patent: 2478
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 10253770
Estimated Expiration: ⤷  Sign Up

Patent: 10253776
Estimated Expiration: ⤷  Sign Up

Patent: 10253950
Estimated Expiration: ⤷  Sign Up

Patent: 15201037
Estimated Expiration: ⤷  Sign Up

Patent: 17201709
Estimated Expiration: ⤷  Sign Up

Patent: 18282272
Estimated Expiration: ⤷  Sign Up

Patent: 20210160
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 1011220
Estimated Expiration: ⤷  Sign Up

Patent: 1011229
Estimated Expiration: ⤷  Sign Up

Patent: 1011508
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 63936
Estimated Expiration: ⤷  Sign Up

Patent: 63939
Estimated Expiration: ⤷  Sign Up

Patent: 63941
Estimated Expiration: ⤷  Sign Up

China

Patent: 2458364
Estimated Expiration: ⤷  Sign Up

Patent: 2596176
Estimated Expiration: ⤷  Sign Up

Patent: 2753152
Estimated Expiration: ⤷  Sign Up

Patent: 5193773
Estimated Expiration: ⤷  Sign Up

Patent: 7412212
Estimated Expiration: ⤷  Sign Up

Patent: 7669664
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0161098
Estimated Expiration: ⤷  Sign Up

Patent: 0161101
Estimated Expiration: ⤷  Sign Up

Patent: 0161102
Estimated Expiration: ⤷  Sign Up

Patent: 0200166
Estimated Expiration: ⤷  Sign Up

Patent: 0200260
Estimated Expiration: ⤷  Sign Up

Patent: 0200298
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 18030
Estimated Expiration: ⤷  Sign Up

Patent: 18034
Estimated Expiration: ⤷  Sign Up

Patent: 18040
Estimated Expiration: ⤷  Sign Up

Patent: 22732
Estimated Expiration: ⤷  Sign Up

Patent: 22749
Estimated Expiration: ⤷  Sign Up

Patent: 22807
Estimated Expiration: ⤷  Sign Up

Patent: 19031
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 35023
Estimated Expiration: ⤷  Sign Up

Patent: 35024
Estimated Expiration: ⤷  Sign Up

Patent: 35025
Estimated Expiration: ⤷  Sign Up

Patent: 06149
Estimated Expiration: ⤷  Sign Up

Patent: 11926
Estimated Expiration: ⤷  Sign Up

Patent: 11927
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 35023
Estimated Expiration: ⤷  Sign Up

Patent: 35024
Estimated Expiration: ⤷  Sign Up

Patent: 35025
Estimated Expiration: ⤷  Sign Up

Patent: 06149
Estimated Expiration: ⤷  Sign Up

Patent: 11926
Estimated Expiration: ⤷  Sign Up

Patent: 11927
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 69026
Estimated Expiration: ⤷  Sign Up

Patent: 69027
Estimated Expiration: ⤷  Sign Up

Patent: 69307
Estimated Expiration: ⤷  Sign Up

Patent: 18867
Estimated Expiration: ⤷  Sign Up

Patent: 44669
Estimated Expiration: ⤷  Sign Up

Patent: 47095
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 29532
Estimated Expiration: ⤷  Sign Up

Patent: 31229
Estimated Expiration: ⤷  Sign Up

Patent: 31283
Estimated Expiration: ⤷  Sign Up

Patent: 47803
Estimated Expiration: ⤷  Sign Up

Patent: 47823
Estimated Expiration: ⤷  Sign Up

Patent: 47834
Estimated Expiration: ⤷  Sign Up

Patent: 900031
Estimated Expiration: ⤷  Sign Up

Patent: 100018
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6466
Estimated Expiration: ⤷  Sign Up

Patent: 6467
Estimated Expiration: ⤷  Sign Up

Patent: 6468
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 23383
Estimated Expiration: ⤷  Sign Up

Patent: 73012
Estimated Expiration: ⤷  Sign Up

Patent: 73013
Estimated Expiration: ⤷  Sign Up

Patent: 69639
Estimated Expiration: ⤷  Sign Up

Patent: 89356
Estimated Expiration: ⤷  Sign Up

Patent: 48645
Estimated Expiration: ⤷  Sign Up

Patent: 92124
Estimated Expiration: ⤷  Sign Up

Patent: 76734
Estimated Expiration: ⤷  Sign Up

Patent: 12528199
Estimated Expiration: ⤷  Sign Up

Patent: 12528200
Estimated Expiration: ⤷  Sign Up

Patent: 12528792
Estimated Expiration: ⤷  Sign Up

Patent: 15187108
Estimated Expiration: ⤷  Sign Up

Patent: 15199735
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Patent: 16041713
Estimated Expiration: ⤷  Sign Up

Patent: 17222706
Estimated Expiration: ⤷  Sign Up

Patent: 18008942
Estimated Expiration: ⤷  Sign Up

Patent: 18048150
Estimated Expiration: ⤷  Sign Up

Patent: 19108369
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 435024
Estimated Expiration: ⤷  Sign Up

Patent: 435025
Estimated Expiration: ⤷  Sign Up

Patent: 2019014
Estimated Expiration: ⤷  Sign Up

Patent: 2021511
Estimated Expiration: ⤷  Sign Up

Patent: 35023
Estimated Expiration: ⤷  Sign Up

Patent: 35024
Estimated Expiration: ⤷  Sign Up

Patent: 35025
Estimated Expiration: ⤷  Sign Up

Patent: 06149
Estimated Expiration: ⤷  Sign Up

Patent: 11926
Estimated Expiration: ⤷  Sign Up

Patent: 11927
Estimated Expiration: ⤷  Sign Up

Luxembourg

Patent: 0124
Estimated Expiration: ⤷  Sign Up

Patent: 0208
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 7126
Estimated Expiration: ⤷  Sign Up

Patent: 0163
Estimated Expiration: ⤷  Sign Up

Patent: 0164
Estimated Expiration: ⤷  Sign Up

Patent: 11012684
Estimated Expiration: ⤷  Sign Up

Patent: 11012685
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Patent: 11012783
Estimated Expiration: ⤷  Sign Up

Patent: 20004077
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 631
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0995
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 19026
Estimated Expiration: ⤷  Sign Up

Patent: 21019
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 017500778
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 35023
Estimated Expiration: ⤷  Sign Up

Patent: 35024
Estimated Expiration: ⤷  Sign Up

Patent: 35025
Estimated Expiration: ⤷  Sign Up

Patent: 06149
Estimated Expiration: ⤷  Sign Up

Patent: 11926
Estimated Expiration: ⤷  Sign Up

Patent: 11927
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 35023
Estimated Expiration: ⤷  Sign Up

Patent: 35024
Estimated Expiration: ⤷  Sign Up

Patent: 35025
Estimated Expiration: ⤷  Sign Up

Patent: 06149
Estimated Expiration: ⤷  Sign Up

Patent: 11926
Estimated Expiration: ⤷  Sign Up

Patent: 11927
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 80315
Estimated Expiration: ⤷  Sign Up

Patent: 86297
Estimated Expiration: ⤷  Sign Up

Patent: 13404
Estimated Expiration: ⤷  Sign Up

Patent: 51771
Estimated Expiration: ⤷  Sign Up

Patent: 11152960
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Patent: 11154083
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Patent: 11154148
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Patent: 15151358
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Patent: 16107464
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Patent: 16117972
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Patent: 20102859
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San Marino

Patent: 01600326
Estimated Expiration: ⤷  Sign Up

Patent: 01600327
Estimated Expiration: ⤷  Sign Up

Patent: 01600329
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 35023
Estimated Expiration: ⤷  Sign Up

Patent: 35024
Estimated Expiration: ⤷  Sign Up

Patent: 35025
Estimated Expiration: ⤷  Sign Up

Patent: 06149
Estimated Expiration: ⤷  Sign Up

Patent: 11926
Estimated Expiration: ⤷  Sign Up

Patent: 11927
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1108275
Estimated Expiration: ⤷  Sign Up

Patent: 1208100
Estimated Expiration: ⤷  Sign Up

Patent: 1208101
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Patent: 1208102
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South Korea

Patent: 1748892
Estimated Expiration: ⤷  Sign Up

Patent: 1926060
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Patent: 1976107
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Patent: 120015334
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Patent: 120026075
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Patent: 120034631
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Patent: 170070274
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Patent: 170104003
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Patent: 180130602
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Patent: 190049943
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Spain

Patent: 89135
Estimated Expiration: ⤷  Sign Up

Patent: 92536
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Patent: 93429
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Patent: 72253
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Patent: 74367
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Patent: 74391
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Taiwan

Patent: 39979
Estimated Expiration: ⤷  Sign Up

Patent: 46094
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Patent: 32926
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Patent: 33898
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Patent: 46980
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Patent: 95723
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Patent: 07700
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Patent: 17511
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Patent: 92140
Estimated Expiration: ⤷  Sign Up

Patent: 1109049
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Patent: 1109050
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Patent: 1109051
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Patent: 1642836
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Patent: 1700123
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Patent: 1808372
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Patent: 1919730
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Patent: 1936174
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Patent: 2114642
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Ukraine

Patent: 9529
Estimated Expiration: ⤷  Sign Up

Patent: 9530
Estimated Expiration: ⤷  Sign Up

Patent: 9531
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BREZTRI AEROSPHERE around the world.

Country Patent Number Title Estimated Expiration
San Marino T201600327 COMPOSIZIONI PER IL RILASCIO POLMONARE DI ANTAGONISTI MUSCARINICI AD AZIONE PROLUNGATA E DI AGONISTI DEL RECETTORE ADRENERGICO BETA 2 AD AZIONE PROLUNGATA E METODI E SISTEMI ASSOCIATI ⤷  Sign Up
Lithuania 3106149 ⤷  Sign Up
Russian Federation 2011154083 КОМПОЗИЦИИ ДЛЯ РЕСПИРАТОРНОЙ ДОСТАВКИ АКТИВНЫХ ВЕЩЕСТВ И СВЯЗАННЫЕ С НИМИ СПОСОБЫ И СИСТЕМЫ ⤷  Sign Up
Lithuania C2435025 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BREZTRI AEROSPHERE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 LUC00124 Luxembourg ⤷  Sign Up PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435024 15/2021 Austria ⤷  Sign Up PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435024 CR 2021 00014 Denmark ⤷  Sign Up PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210
2435025 2019C/532 Belgium ⤷  Sign Up PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.